Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the device was fractured.Attempt for further information has been made, but no further information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of repeated use, the tip is cracked and it fractured due to bending overload.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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